CompletedNot Applicable

Low Molecular Weight hEparin vs. Aspirin Post-partum

Canada30 participantsStarted 2021-08-29

Plain-language summary

This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
. Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
. \> 18 years of age.

Exclusion criteria

. Pre-existing indication for therapeutic LMWH
. Contraindication to ASA:
. Known ASA allergy
. Documented history of gastrointestinal ulcer
. Known platelet count \< 50x10\^9/L at any time during the current pregnancy or postpartum
. Contraindication to LMWH, e.g. known allergy
. Active bleeding at any site, excluding physiological vaginal bleeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Enrollment Rate

Timeframe: 1 year

Consent Rate

Timeframe: 1 year

Adherence to Prescription

Timeframe: 6 weeks

Withdrawal of consent rate

Timeframe: 1 year

Rates of contamination

Timeframe: 6 weeks

Trial details

NCT IDNCT05058924

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-29

View on ClinicalTrials.gov More Venous Thromboembolism trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
. Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
. \> 18 years of age.

Exclusion criteria

. Pre-existing indication for therapeutic LMWH
. Contraindication to ASA:
. Known ASA allergy
. Documented history of gastrointestinal ulcer
. Known platelet count \< 50x10\^9/L at any time during the current pregnancy or postpartum
. Contraindication to LMWH, e.g. known allergy
. Active bleeding at any site, excluding physiological vaginal bleeding